ProjectSummary Althoughwidespreadscreeningbymammographyhassuccessfullycutmortalityfrombreastcancer(BCa), theexquisitesensitivityofthetechniqueresultsinastartlingnumberof?falsepositives.?Ofapproximately3.9 millionwomenwhoreceiveapositivemammogrameachyear,fewerthan250,000willbediagnosedwithBCa. Cumulatively,theeconomiccostoffollow-updiagnosticstoresolvefalse-positivemammogramsis approximately$4billionannually,whilethesocialconsequencesincludelostproductivityandmorethan3 millionwomenexposedtotherisksassociatedwithsubsequentdiagnosticsandtreatment(e.g.,radiation exposure,painanddiscomfortfollowingabreastbiopsy,etc.).Hence,aminimallyinvasive,rapid,and inexpensivebloodtestthatcouldbeusedasa?rule-out?screenforBCafollowingapositivemammogram potentiallyofferssignificanthealthcaresavingandreducedpatientburden. Currentlyavailablecommercialplatformsformeasuringbiomarkerssufferfromnarrowdetectionrange and/orlowthroughput.Inturn,theselimitationsconstrainthedesignofdiagnostictestsbasedonbiomarkers, whichrestrictstheirclinicalutility.Tosurmountthesechallenges,Inanovatereimaginedtheapproachto biomarkerdetection.Theresultisasuperiorbiochipplatform,theBio-ID,whichcandetectbiomarkers(e.g., autoantibodiestotumor-associatedantigens)acrossa7-logrange.Forcomparison;?thebestcompetitor platformavailablecoversonlya4-logrange.Inaddition,theBio-IDsystemisahigh-throughputformatthatcan beconfiguredtodetectanycombinationofbiomarkers,makingitapowerfultoolforclinicalandR&Dtoolfor designingnext-generationbiomarker-baseddiagnosticassays. InthisFast-trackSBIR,InanovateseekstoadvancetheBio-IDplatformtowardcommerciallaunchandto demonstrateitsutilitybydevelopingaBCadiagnosticthatcanbeusedtoexcludeabreastcancerdiagnosis followingapositivescreeningmammogram.Thetestisbasedonanovelpanelof31BCaandimmunesystem biomarkersidentifiedbyInanovateanditscollaboratorsatSanfordResearch.InPhaseI,thebiochipassaywill beoptimizedontheBio-IDsystem(Aim1),andthesystemwillbebenchmarkedtopreviouslycharacterized patientsamplesandasingle-samplepredictivemodelfordifferentiatinghealthyandcanceroussampleswillbe constructed(Aim2).InPhaseII,InanovatewillprototypeanupgradedBio-IDsystemfordeploymentinclinical diagnosticlaboratories(Aim1),thepredictivemodelfromPhaseIwillbechallengedwithalargerdataset(Aim 2),andInanovatewillprepareforregulatoryapprovalsandsecurecommercialpartnerstoadvancethe platformanddiagnostictesttomarket(Aim3).Thesuccessfulcompletionofthisworkwillyieldacost-saving BCadiagnostic(comparedtobiopsy)andadvancearevolutionarynewplatformthatwillfacilitatebiomarker researchandenablethenextgenerationofdiagnosticstobedeveloped.